Rivkin Radler’s Marc Ullman was quoted in the NutraIngredients-USA article, “COVID-19 and legal chaos dent CBD market – but Congress and a stronger economy offer hope.” The article discusses the state of the CBD market amid the COVID-19 pandemic and legal battles.
“The market is a mess and the FDA doesn’t want to
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has pursued its HIPAA Right of Access Initiative since 2019. OCR’s 19th settlement under the initiative, with The Diabetes, Endocrinology & Lipidology Center, Inc. (DELC), curiously resulted in only a $5,000 fine. The West Virginia provider treats patients who have endocrine disorders.
On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted devices, external devices like insulin pumps and pulse oximeters, and any other devices that may be brought into MRI rooms, but not to
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that certain investments by a health system, manager and physicians in an ambulatory surgery center (ASC) did not create a substantial risk of fraud and abuse under the federal Anti-Kickback Statute (AKS) even though the
New York and New Jersey recently legalized recreational marijuana within less than 6 weeks of each other. While both acts prohibit employers from taking action against employees at least 21 years old who use marijuana recreationally and restrict employers from denying these employees’ employment rights and privileges based solely on marijuana use, it begs the
In an April 15 notice on its COVID-19 portal, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) reminded healthcare providers that COVID-19 vaccines must be administered at no out-of-pocket cost to patients. OIG has received complaints from patients that their providers charged them for COVID-19 vaccines.
Under the Centers for
On April 6, Rivkin Radler’s Ben Malerba gave a presentation to members of the Coalition for Behavioral Health. The presentation was entitled “HIPAA in an Evolving Health Care Environment: Proposed Changes for 2021 and Response to COVID-19.”
The Coalition for Behavioral Health provides policy, advocacy, training and technical assistance to more than 100 community-based behavioral
On February 16, 2021, the Governor enacted the Child-Parent Security Act (“the Act”) through emergency regulations, legalizing compensated gestational surrogacy in New York State.
With gestational surrogacy, a surrogate gestates an embryo for the intended parents. The embryo may contain the genetic material of the intended parents or donor gametes. Traditional surrogacy, where the
In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from
A March 24 article in Wolters Kluwer’s Health Law Daily, “STRATEGIC PERSPECTIVES: Pandemic response, fraud and abuse top Biden’s enforcement priorities,” quoted healthcare industry experts who predict increased enforcement in the areas of fraud and abuse, False Claims Act (FCA) cases, and pandemic-related waivers. Rivkin Radler’s Robert Hussar was quoted in the